Symbiotec: Global API manufacturer, specializing in Cortico-Steroids & Steroid-Hormone APIs.
KEY PRODUCTS
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01 1Symbiotec Pharmalab
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01 1TESTOSTERONE ENANTHATE, USP
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01 1India
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01 1Active
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01 1Complete
GDUFA
DMF Review : Complete
Rev. Date : 2018-09-26
Pay. Date : 2018-04-17
DMF Number : 26166
Submission : 2012-06-19
Status : Active
Type : II
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Symbiotec Pharmalab Private Ltd, based in India, is a pharmaceutical company that stands out with its certifications from FDA, EDQM and WHO-GMP.
They are recognized for Symbiotec: Global API manufacturer, specializing in Cortico-Steroids & Steroid-Hormone APIs.
One of their notable products is TESTOSTERONE ENANTHATE, USP, with a corresponding US DMF Number 26166.
Remarkably, this DMF maintains an Active status since its submission on June 19, 2012, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of September 26, 2018, and payment made on April 17, 2018, indicating their dedication to facilitating drug approvals, Categorized as Type II